AIDS (Acquired Immune Deficiency Syndrome) is viewed as one of the most serious modern-day health issue affecting society. Since there is presently no known cure for the disease, early detection and treatment of the HIV virus provides the best chance of helping a patient to prolong his or her life by delaying onset of the disease. In addition, early detection is crucial to preventing the spread of the virus itself.
Although early detection of the virus is vitally important, only about 8% of adult Americans are tested annually. Individuals have been reluctant to submit to testing because, among other things, they fear that a positive test result will not be kept confidential. It is currently estimated that if a diagnostic procedure which could assure an individual's confidentiality was available, the number of at-risk individuals being tested for the HIV virus would increase to approximately 29%.
The present invention relates to a confidential at-home testing system for determining whether an individual may be carrying the HIV virus. An individual uses the at-home system by purchasing a test kit at a pharmacy or other retail outlet. The test kit contains, among other items, a test card for carrying a sample of the individual's blood to a testing lab. The individual places several drops of blood on a designated area on the test card comprising filter paper, or other suitable material, while at home. The individual then mails or otherwise delivers or transmits the test card to a central laboratory for testing. Several days later, the individual calls a central phone number or otherwise contacts the central laboratory to get test results and to receive counseling on the HIV virus and AIDS.
In the case of individuals testing positive for the HIV virus, incoming calls placed to the central phone number are routed to telesets staffed by live counselors for handling. Since numerous telephone calls must be handled simultaneously by the system, each caller that has tested positive for the HIV virus will be routed to a teleset associated with one of a plurality of live counselors.
In order to maintain the effectiveness and integrity of a testing system such as the one described above, the system should have mechanisms for monitoring: (i) whether the individual's test specimen (typically in the form of a test card or dried blood spot (DBS) punched from the test card) has been received by the central laboratory for testing; (ii) whether testing has commenced or has been completed on the specimens received; (iii) the location of the specimen at any given time; (iv) whether an individual's test results have been reported to the individual and, if so, how many times; (v) whether an individual has been counselled by the testing system and, if so, concerning which topics, and how many times; and (vi) the length of time since the individual's test results were analyzed by the testing lab. In addition to monitoring these parameters, the testing system must also be able to deliver confidential test results and counselling to numerous individuals over the telephone in an efficient and cost-effective manner.
In the case where a client has tested HIV positive, a live counselor will not only inform the client-caller of the test results, but may also counsel the client on various aspects of HIV and AIDS. In order for the live counselor to handle the call properly, the counselor must be apprised of all available laboratory information about the client-caller (e.g., the date the testing laboratory received the client's specimen, the date the testing laboratory completed its testing of the client's specimen, whether the client has called the counseling center previously and, if so, the date and time of such calls and a list of the topics discussed during such calls, etc.) simultaneous to call. A workstation positioned in front of each live counselor is provided for displaying such information about the client-caller.
In view of the foregoing, it is apparent that the need exists for a system which automatically identifies, handles, tracks and processes blood samples in HIV-1 testing as quickly and as accurately as existing HIV testing techniques will permit. Moreover, because the blood samples provided by a non-professional user will vary greatly in size, shape and blood concentration, the need exists for a system which has the capability of automatically selecting the portion of the blood sample which will return the most accurate result as well as yield the greatest number of dried blood spots from the blood provided.
To date, certain process steps in the testing of blood samples, particularly blood samples which are in the form of dried blood spots (DBS) on filter paper, have been entirely manual or semi-automated process steps. One such step comprises punching a substantially circular DBS of a predetermined diameter from filter paper typically found on a test card. Although certain manual and semi-automatic devices exist to carry out this process, such devices generally require an operator to physically position the test card in a standard male die-type punch. These devices comprise dies which are dedicated to punching DBSs of a single size. Typically, these devices punch a 1/4" diameter DBS from a blood sample spot which may range from 1/2" to 5/8" diameter. Two such devices are produced by I.E.M. of North Hollywood, Calif. and BSD Technologies International of Austria. These punches are typically tooled such that a DBS is punched from a preset location on the test card. The punched DBS is also generally smaller in size than that of the DBS itself.
Because individual users will deposit blood samples of varying amounts and shapes on different areas of the card, there will exist areas on the card which contain higher blood concentrations more desirable for testing purposes. Because current semiautomatic punching devices do not allow for the selection of the most desirable DBS location within the blood sample there becomes a need for an apparatus and method for automatically punching DBSs from that area.
In addition, because the amount of blood sample available to the testing facility is limited, it is desirable to obtain as many DBSs from each blood sample as possible. Accordingly, there exists a need for a device that may punch DBSs which have a smaller surface area than a 1/4" diameter DBS.
Furthermore, in order to speed the overall testing process while achieving maximum accuracy of testing, there exists the need for a device which automatically (1) transports a test card to a punching station; (2) selects the most desirable area of a blood spot to be punched; (3) punches a DBS directly into a test receptacle (such as an elution plate or Western Blot tray); (4) transports the test receptacle for further processing; and (5) tracks the identity and location of the particular DBS throughout the process and makes available the test results, all while maintaining the anonymity of the test subject.
Accordingly, it is an object of the present invention to provide a system which automatically identifies, handles, tracks and processes blood samples in the form of dried blood spots.
It is a further object of this invention to provide a system which compiles and reports test result data related to particular blood samples.
It is yet a further object of this invention to provide an automatic system which automatically handles test cards containing blood samples and incubation receptacles, punches DBSs of a desirable or optimum size and location on the test card into individual incubation receptacles, tracks the identity and location of an individual DBS at any time and reports such information to a central monitoring site for delivery of test results.
It is still a further object of this invention to provide an automatic system which, prior to punching, analyzes a blood sample contained on a test card and detects a preferred area to be punched and utilized for testing purposes.
It is yet a further object of this invention to provide an automatic system for punching optimum or desired DBSs from test cards directly into individual incubation receptacles at a rapid rate while maximizing the speed and reliability of such a process.
These and other objects of the present invention will become apparent upon study of the accompanying drawings and description of the invention.